DESCRIPTION: State the application's broad, long-term objectives and specific aims, making reference to the health relatedness of the project. Describe concisely the research design and methods for achieving these goals. Avoid summaries of past accomplishments and the use of the first person. This abstract is meant to serve as a succinct and accurate description of the proposed work when separated from the application. If the application is funded, this description, as is, will become public information. Therefore, do not include proprietary/confidential information. DO NOT EXCEED THE SPACE PROVIDED. Producing leaders in clinical research is a major goal at UT Southwestern. Over the past four years our K30 training program in patient-oriented research (POR) has enrolled over 130 trainees, 65 of whom remain active, and 34 have submitted over 120 grants of which 43% have been funded. Thirty additional full-time faculty mentors have been recruited among whom 17 are basic scientists. In this competitive renewal application we intend to move closer to our goal by fulfilling the following Specific aims: 1) Provide in-depth training and practical experience to foster development of independent (RO-1 funded) -investigators by: a) expanding the curriculum with new interactive courses in genetics and proteomics, clinical pharmacology and drug development, grant writing, translational research, and management; b) creation of dual mentorship of trainees by basic and clinical researchers to enhance scientific rigor and translational research; c) providing practical experience in a mentored POR project; d) beginning the process of writing and submitting a career development award application. In addition, our expanded K30 curriculum will serve as a template for a Masters Degree program in POR, support mentorship as an academic activity and catalyze further procurement of T32, K12, K24 and F32 grants; and 2) Evolve the training program into a self-sustaining (K30-independent) program by the year 2010. To accomplish this aim we will integrate administrative, mentoring and didactic training components into the new Department of Biostatistics and Clinical Science at UT Southwestern, a core clinical research education, training and service facility for Clinical researchers that will become an Academic department in 2004. Our new expanded curriculum is ,comprehensive, broad-based and takes advantage of the best basic and clinical science resources at UT Southwestern. Continuing support of this grant is critical for UT Southwestern's mission and will ensure that our training program in POR continues to be highly successful and on track to produce leaders in POR. PERFORMANCE SITE(S) (organization, city, state) UT Southwestern Medical Center Dallas Dallas, Texas KEY PERSONNEL. See instructions. Use continuation pages as needed to provide the required information Start with Principal Investigator. List all other key personnel in alphabetical order, last name first. Name Organization Toto, Robert D UT Southwestern Adams, Karen UT Southwestern Adams, Perrie UT Southwestern Aragaki, Corinne UT Southwestern Caetano, Raul UT Southwestern Chappel, William UT Southwestern Fischbach, Lori UT Southwestern Grinnell, Fred UT Southwestern Haley, Robert UT Southwestern Jarrett, Robin UT Southwestern Packer, Milton UT Southwestern Reisch, Joan UT Southwestern Disclosure Permission Statement, Applicable to SBIR/STTR Only. See instructions. I-7 Yes I-'1No PHS 398 (Rev. 05/01) Page 2 Number pages consecutively at the bottom throughout Form Page 2 the application. Do not use suffixes such as 2a, 2b. in the format shown below. Role on Project PI Lecturer Co-Director Co-Investigator Co-Investigator Lecturer Co-Investigator Course Director Mentor, Committee member Lecturer Mentor, Committee member Course Director PrincipInavlestigator/PDriorecgtoram(Last, First, Middle): Toto, Robert D. List of Mentors Abhimanyu Garg, M.D. Professor 2 Benjamin Levine, M.D. Professor 3 Bruce Carr, M.D.* Professor 4 Burton Combes, M.D. Professor 5 Carol Tamminga, M.D.* Professor 6 Charles Pak. M.D. Professor 7 Claus Roehrborn, M.D. Professor 8 David Miller, M.D. Professor 9 Elie Benaim, Ph.D.* Professor 10 Ellen Vitetta, Ph.D.* Professor 11 Eric Nestler, M.D. Ph.D.* Professor 12 George Buchanan, M.D. Professor 13 Helen Hobbs, M.D.* Professor 14 John Rush, M.D. Professor 15 Jureta Horton, Ph.D.* Professor 16 Kenneth Leveno, M.D. Professor 17 Khashayar Sakhaee, M.D. Professor 18 Madhukar Trivedi, M.D., Ph.D. Professor 19 Michael McPhaul, M.D.* Professor 20 Orson Moe, M.D.* Professor 21 Patricia Preisig, Ph.D.* Professor 22 Patricia Suppes, M.D., Ph.D. Professor 23 Paul Bergstresser, M.D.* Professor 24 Paul White, M.D. PhD. Professor 25 Perrin White, M.D.* Professor 26 Philip Raskin, M.D. Professor 27 Robert Haley, M.D. Professor 28 Robert Munford, M.D.* Professor 29 Ronald Victor, M.D. Professor 30 Scott Grundy, M.D., Ph.D. Professor 31 William Lee, M.D. Professor 32 Craig Rubin, M.D. Professor 33 Daniel Keyes. M.D. Assoc. Prof. 34 Gail Tomlinson, M.D. Ph.D* Assoc. Prof. 35 Joseph Schaeffer, M.D. Assoc. Prof. 36 Michael Racke, M.D. Assoc. Prof. 37 Robert Wiebe, M.D. Professor 38 Ronald Peshock, M.D.* Professor PHS 398/2590 (Rev. 05/01) Page 3. Assoc. Director GCRC, Internal Medicine Director Institute for Exercise and Environmental Medicine, Internal Medicine Obstetrics and Gynecology Chief Liver Unit, Internal Medicine Chair in Brain Science, Neurology Internal Medicine Chairman Urology, Surgery Chief. Gynecologic Oncology Urology The Scheryle Simmons Patigian Distinguished Chair in Cancer Immunobiology, Immunology Chairman, Psychiatry Chief Pediatric Heme-Oncology Chief, Molecular Genetics Vice Chair Research, Psychiatry Surgery Obstetrics and Gynecology Director GCRC, Internal Medicine Psychiatry Director, Doris Duke Program Director Mineral Metabolism Internal Medicine Psychiatry Chief Dermatology, Internal Medicine Chairman, Anesthesiology Pediatrics Chief, Clinical Diabetes Chief Epidemiology, Internal Medicine Internal Medicine Chief Hypertension Division Director, Center for Human Nutrition Liver Unit, Internal Medicine Chief Geriatrics, Internal Medicine Emergency Medicine Pediatrics Obstetrics and Gynecology Associate Director Research, Neurology Chief Emergency Medicine, Pediatrics Director, Bioinformatics continuation Format Page Principal Investigator/Program Director (Last, First, Middle): Toto, 39 _Milton Packer, M.D. Professor 4O Rebecca Gruchalla, M.D. Ph.D.* Assoc. Prof 41 Joseph Hill, M.D. Ph.D.* Assoc. Prof. 42 Gloria L. Vega, Ph.D. Professor 43 Robert Collins, M.D. Assoc. Prof. 44 Fiemu Nwariku, M.D.* Assoc. Prof. 45 Harold Garner, Ph.D.* Assoc. Prof. Robert D. Director, Ctr. Biostatistics and Clin. Sci. Chief, Allergy Division Chief, Cardiology Division Department of Human Nutrition Oncologist, Cancer Center Surgery Human Growth and Development PHS 398/2590 (Rev. 05/01) Page. 4 Continuation Format Page Principal Investigator/Program Director (Last, first, middle): Toto, Robert D The name of the principal investigator/program director must be provided at the top of each printed page and each continuation page. RESEARCH GRANT